Sumitomo Pharma
Associate Director, Regulatory Affairs
Sumitomo Pharma, Pierre, South Dakota, United States, 57501
Sumitomo Pharma Associate Director, Regulatory Affairs Pierre, South Dakota Apply Now
Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. For more information on SMPA, visit our website
here
or follow us on
LinkedIn . Job Overview We are currently seeking a dynamic, highly motivated, and experienced individual for the position of
Associate Director, Regulatory Affairs . The Associate Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily function as a Regional Regulatory Leader (RRL) and is responsible for ensuring the execution of regional regulatory strategy in line with the global registration strategy of a project in collaboration with the Global Regulatory Leader (GRL). He/she is expected to provide regulatory support from proof of concept (PoC), development, registration, and post-approval for projects within the company’s portfolio. Depending on the candidate’s skill-set, may also be assigned as a Global Regulatory Leader (GRL) with full regulatory responsibility for one or more earlier stage projects and/or commercial assets. This position is also responsible for providing internal expertise on FDA regulations governing promotion and advertising of assigned products. This position has a moderate-high level of autonomy but may require some coaching and mentoring. Job Duties and Responsibilities Manage regional (United States and/or European) regulatory activities as part of a Global Regulatory Team (GRT). Ensure execution of regional regulatory plans in line with the global registration strategy in collaboration with the GRL. Lead preparation, coordination, authoring and monitoring of submissions (e.g., IND/NDA submissions, annual reports, investigator brochures, IND amendments, briefing book for FDA meetings) and responses to HA information requests. Represent GRA on less complex project-related meetings and provide regulatory input as appropriate. Assess and communicate regulatory requirements ensuring activities are in compliance with applicable regulations and guidelines. Lead the documentation of regulatory interactions including decisions and outcomes. Provide updates at the GRT meetings and project teams as needed. Collaborate effectively with Regulatory Operations Leader (ROL). Review nonclinical, clinical and CMC documentation and contribute to content as needed. Advise team members of major regulatory issues and provide possible solutions, leading the mitigation strategy. Lead and coordinate local project team members in developing strategy for applicable documents/activities. Ensure quality and content of submissions to Health Authorities. Assist with development of the global regulatory functional plan through research, review and interpretation of related product approvals. Accountable in conjunction with the GRL for developing and maintaining the development core data sheet (DCDS) if required. Ensure compliance with global regulatory requirements and adherence to regulatory internal policies. Participate in the promotional materials review committee (PMRC) along with Marketing Brand Teams. Conduct regulatory review of promotional and non-promotional materials in accordance with business goals. Key Core Competencies Strong verbal and written communication, interpersonal, listening, and organizational skills. Unquestionable ethics and professional integrity. Ability to work in a diverse environment. Demonstrated ability to adapt to changing priorities. Experience contributing to electronic regulatory submissions. Solid understanding of medical terminology, FDA and ICH regulations. Experience reviewing nonclinical, clinical and CMC documentation. Proven success in major submissions and approvals. Education and Experience Doctorate preferred (Pharm.D., Ph.D., M.D., etc.). Master’s degree required (preferably in a scientific discipline). 6 – 8 years relevant experience in biotech or pharmaceutical industry with a minimum of 6 years focused in Regulatory Affairs. The base salary range for this role is $153,700 to $192,100, including a total rewards package. Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) and Affirmative Action employer committed to a culturally diverse workforce. Confidential Data : All information encountered is considered confidential. Compliance : Achieve and maintain compliance with all applicable regulatory, legal and operational rules. Mental/Physical Requirements : Fast-paced environment, requires high initiative and independence.
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Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. For more information on SMPA, visit our website
here
or follow us on
LinkedIn . Job Overview We are currently seeking a dynamic, highly motivated, and experienced individual for the position of
Associate Director, Regulatory Affairs . The Associate Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily function as a Regional Regulatory Leader (RRL) and is responsible for ensuring the execution of regional regulatory strategy in line with the global registration strategy of a project in collaboration with the Global Regulatory Leader (GRL). He/she is expected to provide regulatory support from proof of concept (PoC), development, registration, and post-approval for projects within the company’s portfolio. Depending on the candidate’s skill-set, may also be assigned as a Global Regulatory Leader (GRL) with full regulatory responsibility for one or more earlier stage projects and/or commercial assets. This position is also responsible for providing internal expertise on FDA regulations governing promotion and advertising of assigned products. This position has a moderate-high level of autonomy but may require some coaching and mentoring. Job Duties and Responsibilities Manage regional (United States and/or European) regulatory activities as part of a Global Regulatory Team (GRT). Ensure execution of regional regulatory plans in line with the global registration strategy in collaboration with the GRL. Lead preparation, coordination, authoring and monitoring of submissions (e.g., IND/NDA submissions, annual reports, investigator brochures, IND amendments, briefing book for FDA meetings) and responses to HA information requests. Represent GRA on less complex project-related meetings and provide regulatory input as appropriate. Assess and communicate regulatory requirements ensuring activities are in compliance with applicable regulations and guidelines. Lead the documentation of regulatory interactions including decisions and outcomes. Provide updates at the GRT meetings and project teams as needed. Collaborate effectively with Regulatory Operations Leader (ROL). Review nonclinical, clinical and CMC documentation and contribute to content as needed. Advise team members of major regulatory issues and provide possible solutions, leading the mitigation strategy. Lead and coordinate local project team members in developing strategy for applicable documents/activities. Ensure quality and content of submissions to Health Authorities. Assist with development of the global regulatory functional plan through research, review and interpretation of related product approvals. Accountable in conjunction with the GRL for developing and maintaining the development core data sheet (DCDS) if required. Ensure compliance with global regulatory requirements and adherence to regulatory internal policies. Participate in the promotional materials review committee (PMRC) along with Marketing Brand Teams. Conduct regulatory review of promotional and non-promotional materials in accordance with business goals. Key Core Competencies Strong verbal and written communication, interpersonal, listening, and organizational skills. Unquestionable ethics and professional integrity. Ability to work in a diverse environment. Demonstrated ability to adapt to changing priorities. Experience contributing to electronic regulatory submissions. Solid understanding of medical terminology, FDA and ICH regulations. Experience reviewing nonclinical, clinical and CMC documentation. Proven success in major submissions and approvals. Education and Experience Doctorate preferred (Pharm.D., Ph.D., M.D., etc.). Master’s degree required (preferably in a scientific discipline). 6 – 8 years relevant experience in biotech or pharmaceutical industry with a minimum of 6 years focused in Regulatory Affairs. The base salary range for this role is $153,700 to $192,100, including a total rewards package. Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) and Affirmative Action employer committed to a culturally diverse workforce. Confidential Data : All information encountered is considered confidential. Compliance : Achieve and maintain compliance with all applicable regulatory, legal and operational rules. Mental/Physical Requirements : Fast-paced environment, requires high initiative and independence.
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